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Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease

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ClinicalTrials.gov Identifier: NCT02969941
Recruitment Status : Completed
First Posted : November 21, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
WANG KAI, Anhui Medical University

Brief Summary:
To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI

Condition or disease Intervention/treatment Phase
Transcranial Magnetic Stimulation Functional Magnetic Resonance Imaging Parkinson Disease Other: transcranial magnetic stimulation Not Applicable

Detailed Description:

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to rTMS group and the sham group by coin toss. There are at least 20 patients in each group. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing clinical symptoms. Each patient would be treated for continuous 14 days by rTMS.

Before the rTMS treatment, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale, Stroop test, Iowa gambling test, game of dice test, stop signal test, and delay discount), magnetic resonance imaging scan in multimodalities, and electroencephalography (EEG) record.

In the second day after the last treatment, all the tests were reassessed. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.

The clinical symptom and cognition of participants were followed in two month after the last treatment. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 1, 2016
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Real Stimulation
Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks
Other: transcranial magnetic stimulation
The stimulations were performed by MagStim Rapid2.

Placebo Comparator: Placebo Stimulation
Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks
Other: transcranial magnetic stimulation
The stimulations were performed by MagStim Rapid2.




Primary Outcome Measures :
  1. Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III [ Time Frame: changes from baseline at 2 weeks post-treatment ]
    This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.


Secondary Outcome Measures :
  1. Timed up and go test [ Time Frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment ]
    Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.

  2. 20m walking test [ Time Frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment ]
    The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again.

  3. Non-motor symptoms questionnaire [ Time Frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment ]
    This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity"and "frequency" range from 0 to 3. Higher scores indicate worse symptoms.

  4. Unified Parkinson's Disease Rating Scale III [ Time Frame: changes from baseline at 1, 4, 6, and 10 weeks post-treatment ]
    This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson disease (PD) according to the United Kingdom Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders.
  • Minimum of 3 years since the formal diagnosis of PD, and requiring dopaminergic therapy (at a minimum, on levodopa and/or dopamine agonist therapy).
  • On a stable dose of all medications for 2 months; and no anti-PD medication adjustments in the next 3 months.
  • Age 40 years or older.
  • Mini-mental state examination > 27.

Exclusion Criteria:

  • Any history or clinical signs of other severe psychiatric illnesses (like major depression, psychosis or obsessive compulsive disorder).
  • History of head injury, stroke, or other neurologic disease.
  • Organic brain defects on T1 or T2 images.
  • History of seizures or unexplained loss of consciousness.
  • Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator.
  • Family history of medication refractory epilepsy.
  • History of substance abuse within the last 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969941


Locations
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China, Anhui
Anhui Medical University
Hefei, Anhui, China, 230032
Sponsors and Collaborators
Anhui Medical University

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Responsible Party: WANG KAI, Director of medical psychological department, Anhui Medical University
ClinicalTrials.gov Identifier: NCT02969941     History of Changes
Other Study ID Numbers: NSFC-81171273-02
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by WANG KAI, Anhui Medical University:
Parkinson Disease
Functional Magnetic Resonance Imaging
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases